Bexsero

Bexsero

vaccine, meningococcal

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Meningococcal group B vaccine (rDNA, component, adsorbed)
Indications/Uses
Active immunisation of individuals ≥2 mth of age against invasive meningococcal disease caused by Neisseria meningitidis group B.
Dosage/Direction for Use
IM Adult, adolescent ≥11 yr & childn 2-10 yr Primary immunisation: 2 doses w/ not less than 1 mth intervals between primary doses. Booster: Consider in individuals at continued risk of exposure. Childn 12-23 mth Primary immunisation: 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose w/ 12-23 mth intervals between primary series & booster dose. Infant 6-11 mth Primary immunisation: 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose in the 2nd yr of life w/ at least 2 mth intervals between primary series & booster dose. Infant 2-5 mth Primary immunisation: 3 doses w/ not less than 1 mth intervals between primary doses, or 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose between 12 & 15 mth of age w/ at least 6 mth intervals between primary series & booster dose.
Contraindications
Special Precautions
Anaphylactic event following vaccination. Do not inj intravascularly, subcutaneously or intradermally. Postpone vaccination in case of acute severe febrile illness. Risk of temp elevation following vaccination in infants & childn <2 yr. Do not give to individuals w/ thrombocytopenia or any coagulation disorder. Not expected to provide protection against all circulating meningococcal group B strains. Reduced Ab response in individuals w/ impaired immune responsiveness. Increased risk for invasive disease caused by Neisseria meningitidis group B in individuals w/ familial complement deficiencies (eg, C3 or C5 deficiencies) & those receiving treatments that inhibit terminal complement activation (eg, eculizumab). Consider potential risk of apnoea & need for resp monitoring for 48-72 hr when administering primary immunisation series to very premature infants (born ≤28 wk of gestation) & those w/ previous history of resp immaturity. Latex & kanamycin hypersensitivity. May temporarily affect ability to drive or use machines. Pregnancy & lactation. No data in adults & elderly >50 yr. Safety & efficacy in infants <8 wk of age has not yet been established. Limited data in patients w/ chronic medical conditions.
Adverse Reactions
Headache; arthralgia; inj site erythema, swelling & induration. Adults & adolescents ≥11 yr: Nausea; myalgia; inj site pain, malaise. Infants & childn ≤10 yr: Eating disorders; sleepiness, unusual crying; diarrhoea, vomiting; rash; fever ≥38°C, inj site tenderness, irritability.
Drug Interactions
Increased risk of fever, tenderness at inj site, change in eating habits & irritability w/ the following vaccine antigens: diphtheria, tetanus, acellular pertussis, HIB, inactivated poliomyelitis, hepatitis B, heptavalent pneumococcal conjugate, MMR, varicella, & meningococcal group A, C, W, Y conjugate; consider separate vaccinations when possible. Prophylactic use of paracetamol reduces the incidence & severity of fever w/o affecting the immunogenicity of either Bexsero or routine vaccines. Administer at separate inj sites when given concomitantly w/ other vaccines.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AH09 - meningococcus B, multicomponent vaccine ; Belongs to the class of meningococcal bacterial vaccines.
Presentation/Packing
Form
Bexsero vaccine susp for inj 0.5 mL/dose
Packing/Price
1's
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